(106 days)
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes. Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
Here's a breakdown of the acceptance criteria and the study information for the Socket Graft and Socket Seal devices, based on the provided 510(k) summary:
This submission primarily relies on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and clinical outcomes. The "performance testing" section focuses on comparing physical and chemical properties to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For SOCKET GRAFT:
| Acceptance Criteria (compared to predicate K052493) | Reported Device Performance (K113049) | Justification/Comment |
|---|---|---|
| Trace impurities analysis: Pass (NMT 20 PPM) | Pass | Meets USP 34 specification. |
| Particles: None | None | Essential for biocompatibility. |
| Ca/P ratio: Equivalent | Equivalent | Indicates similar chemical composition of bone graft. |
| pH: 7.2 (predicate) | 7.4 | Considered equivalent and within acceptable biological range. |
| Volumetric porosity: 25% (predicate) | Non porous | Difference identified: The K113049 is "non porous" while the predicate is "25%". This difference is explained later by the addition of carboxymethylcellulose (CMC). The submission implies this change does not impact substantial equivalence due to CMC's GRAS status and use in other predicates. |
| Solubility @ 20C: Non soluble | Non soluble | Indicates material stability. |
| Resorption time: 12-14 weeks (predicate) | Earliest implant placement 8 weeks | The resorption time for K113049 is inferred to be similar to the predicate due to the addition of CMC (which also resorbs in 12 weeks) and clinical outcomes from the predicate's use. |
For SOCKET SEAL:
The performance testing for Socket Seal is less detailed and focuses on material similarity to predicate devices rather than specific quantitative criteria beyond material composition. The characteristics listed, such as material (polyethylene), design (sheets), sterility (sterile), sterilization method (gamma), biocompatibility (yes), resorbable/nonresorbable (nonresorbable), and porosity (nonporous), are compared directly to the predicate devices. The acceptance criterion is implicitly that these properties are equivalent to the legally marketed predicate devices.
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: No dedicated test set in the traditional sense of a clinical trial for K113049 is described. The performance assessment relies on non-clinical comparative testing against a predicate device (K052493) for physical and chemical properties.
- Data Provenance: The "published research article" cited for the predicate device (K052493) regarding implant success "The healing socket and socket regeneration. Compend Contin Educ Dent. 2008 Mar;29(2):114-6, 118, 120-4" involved One Hundred implants. The country of origin is not specified, but the publication in a dental journal suggests a clinical context. This is retrospective data used to support the established performance of the predicate, which is then extended to the new device through substantial equivalence arguments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission does not involve an expert-adjudicated test set for performance comparison in the context of diagnostic accuracy or clinical outcomes for the new device. The "ground truth" for the non-clinical comparative tests is based on standard laboratory analysis and established material specifications.
- For the clinical outcomes of the predicate device, "The healing socket and socket regeneration" article would have involved clinical experts (dentists/oral surgeons) for patient follow-up, but their specific number or qualifications are not provided in this 510(k) summary.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication method is described as the "test set" consists of non-clinical material property comparisons and reference to existing literature for the predicate device.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done as this device does not involve human readers evaluating output (e.g., medical images). It is a bone grafting material and a barrier membrane.
6. Standalone (Algorithm Only) Performance Study
- No. This is not a software or AI-driven device, so standalone algorithm performance is not relevant or reported.
7. Type of Ground Truth Used
- For K113049 comparative testing: Laboratory measurements of chemical and physical properties (trace impurities, particles, Ca/P ratio, pH, volumetric porosity, solubility).
- For supporting the predicate device's clinical performance: Clinical outcomes data from a published study on the predicate device, specifically implant integration and function at 3 years after placement in 100 cases. This relies on established clinical practice and patient outcomes.
8. Sample Size for the Training Set
- Not applicable. There is no training set mentioned, as this is a physical medical device (bone graft and barrier), not a device that uses machine learning or requires data for "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
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510(k) Summary
SUMMARY REPORT
JAN 2 7 2012
SUBMITTED BY
Gregory Gene Steiner CEO STEINER LABORATORIES Kapolei, HI 96707 808 689 1710
01/15/2012
This summary of 510k substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92. Socket Graft is intended to be marketed as a kit containing Socket Graft bone grafting material and a barrier membrane titled Socket Seal.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Graft
| Classification Name: | Bone grafting material, synthetic |
|---|---|
| Common/Usual Name: | Bone grafting material |
| Product Classification: | LYC |
| Proprietary Name: | SOCKET GRAFT |
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Seal
| Classification Name: | Barrier, Synthetic, Oral |
|---|---|
| Regulation description: | Bone grafting material |
| Common/Usual Name: | Barrier, Synthetic, Oral |
| Product Classification: | NPK |
| Proprietary Name: | SOCKET SEAL |
SOCKET GRAFT grafting material is substantially equivalent to:
-
- Socket Graft K052493
-
- EquivaBone Osteoinductive Bone Graft K090855
-
- CalMatrix Calcium Sulfate Bone Graft K041324
SOCKET SEAL is substantially equivalent to:
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DEVICE DESCRIPTION
SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes.
Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
INDICATIONS FOR USE
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining.
Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
PERFORMANCE TESTING:
In comparison to the predicate device Socket Graft K052493comparison summary: Non clinical testing.
| Socket Graft predicate K052493 | Socket Graft K113049 | |
|---|---|---|
| Trace impurities analysisReference US pharmacopeia 34specification NMT 20 PPM | pass | pass |
| Particles | none | none |
| Ca/P ratio | equivalent | equivalent |
| Ph | 7.2 | 7.4 |
| volumetricporosity | 25% | non porous |
| Solubility @ 20C | non soluble | non soluble |
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The proposed device Socket Graft K113049 differs in composition only by the addition of sodium salt of carboxymethylcellulose.
The sodium salt of carboxymethylcellulose used in Socket Graft conforms to the GRAS classification 21 CFR 182.1745 with the following analysis:
| reference | test results |
|---|---|
| 99.5% by dry weight | 99.8 |
| max substitution 0.95 | 0.77 |
| minimum viscosity 25 centipoises | 3100 centipoises |
Predicate devices EquivaBone Osteoinductive Bone Graft and CalMatrix Calcium Sulfate Bone Graft both contain comparable amounts of carboxymethylcellulose and both of these predicate devices have used carboxymethylcellulose to increase the viscosity of their graft material in the same manner as the proposed device Socket Graft K113049 . Carboxymethylcellulose has been shown to resorb in 12 weeks in vivo in the following reference "Carboxymethylcellulose-stabilized collagenous rhOP-1 device-a novel carrier biomaterial for the repair of mandibular continuity defects. Wang H et al".
The predicate device Socket Graft K052493 was shown to fully resorb in 12-14 weeks. The timing of implant placement for Socket Graft K113049 is based on published research for the predicate device Socket Graft K052493. In the published research article "The healing socket and socket regeneration. Compend Contin Educ Dent. 2008 Mar;29(2):114-6, 118, 120-4". One Hundred implants were placed on a protocol of 6 weeks for incisors and bicuspids and 8 weeks for molars. All one hundreds implants integrated and all implants were in function 3 years after placement. Therefore, the earliest time point for implant placement in sockets grafted with Socket Graft K113049 is 8 weeks.
Substantial Equivalence:
Socket graft grafting material and Socket Seal shares indications and design principles with the following predicate devices:
| Device name | Proposed Device | Predicate device #1 | Predicate Device #2 | Predicate Device #3 |
|---|---|---|---|---|
| Socket Graft | Socket Graft | EquivaBoneOsteoinductive BoneGraft | CalMatrix CalciumSulfate Bone Graft | |
| 510 K number | K113049 | K052493 | K090855 | K041324 |
| Intended use | SOCKET GRAFT is abone grafting material | SOCKET GRAFT is abone grafting material | EquivaBone is anosteoinductive bone | used to treat multipletypes of maxillary and |
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| indicated for use indental extractionsockets that have allwalls remaining. | indicated for use indental extractionsockets. | graft substitute thatis resorbed andreplaced with newbone during the healingprocess. It is intendedfor use to fill bonyvoids or gaps of theskeletal system of theextremities, spine(i.e.posterolateralspine) and pelvis thatare not intrinsic to thestability of the bonystructure. These voidsor gaps may result fromnatural occurring bonedisease, traumaticinjuryor surgical intervention. | mandibular osseousand periodontal defectssuch as:Intrabony/infrabonydefects, furcationdefects, recessiondefects,dehiscence/fenestration defects (natural teethand prosthetic rootform implants),extraction socket (ridgepreservation) defects,ridge augmentationdefects, sinus liftdefects, endodonticbony defects | |
|---|---|---|---|---|
| Material | A dual phase calciumphosphate biocementplus carboxymethylcellulose(CMC) that is wetted bysterile water to a puttyconsistency. | A dual phase calciumphosphate biocementthat is wetted bysterile water to a pasteconsistency | Synthetic calciumphosphate,carboxymethylcellulose(CMC) anddemineralized bonematrix (DBM) that iswetted by sterile waterto a putty consistency. | A calcium sulfatematerial that containsapproximately 10% ofpharmaceutical gradesodiumcarboxymethylcellulose(CMC) that is wetted bysterile water to a puttyconsistency. |
| Design | Powder, water | Powder, water | Powder, water | Powder, water |
| Sterile/non sterile | Sterile | sterile | Sterile | Sterile |
| Sterilizationmethod | gamma | gamma | gamma | gamma |
| Biocompatible | Yes | yes | yes | yes |
| Resorbable/Nonresorbable | resorbable | resorbable | resorbable | resorbable |
PREDICATE DEVICES for Socket Seal
:
| Device name | Proposed Device | Predicate Device #1 | Predicate Device#2 |
|---|---|---|---|
| Socket Seal | IMTEC BioBarrierMembrane | Tefgen-LS | |
| 510 K number | K113049 | K974752 | K965205 |
| Intended use | A temporaryimplantable materialintended for use in theoral cavity to be used as | A temporary implantablematerial intended to beused in the oral cavity as aspace maintaining barrier | A implant material which isintended to be used in theoral cavity as a temporaryspace making barrier over |
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| a space maintainingbarrier over bone andconnective tissue.Socket Seal is indicatedfor use over bonegrafts. Socket Seal inindicated for use overextraction sockets inthe maxilla andmandible. | over bone. Use inaugmentation aroundimplants placed inimmediate extractionsockets and aroundimplants placed in delayedextraction sockets andshould be used incombination with space-making bone graftmaterial. | bone or other tissue. | |
|---|---|---|---|
| Material | polyethylene | polyethylene | polyethylene |
| Design | sheets | sheets | sheets |
| Sterile/nonsterile | Sterile | Sterile | Sterile |
| Sterilizationmethod | gamma | Not specified | Not specified |
| Biocompatible | Yes | yes | yes |
| Resorbable/Nonresorbable | nonresorbable | nonresorbable | nonresorbable |
| porosity | nonporous | nonporous | nonporous |
Conclusion (statement of equivalence)
The data submitted in this 510(k) supports substantial equivalence of Socket Graft and Socket Seal to the following aforementioned commercially marketed devices.
Substantial equivalence is based on the indications for use, product design and configuration, and materials used. The intended use of Socket Graft K113049 is the same as Socket Graft K052493, and the materials used are the same as those found in Socket Graft K052493 with the exception of the addition of carboxymethyl cellulose(CMC). Socket The comparative analysis demonstrates the substantial equivalence of Socket Graft and Socket Seal to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory G. Steiner CEO STEINER LABORATORIES 590 Farrington Highway, #524 Suite 132 Kapolei, Hawaii 96707
Re: K113049
Trade/Device Name: Socket Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 15, 2012 . Received: January 23, 2012
Dear Mr. Steiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
JAN 2 7 2012
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Page 2 - Mr. Steiner
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
G for Anthony Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known) | K113049, Socket Graft, January 15 2012 |
|---|---|
| Device Name | Socket Graft |
| Indications for Use | SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible." |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
Prescription Use_ X (Per 21 CFR 801. 109)
Over-The-Counter Use_
Susan Kunne
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KII13049 510(k) Number: __
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.